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2016-10-28

Swedish Orphan Biovitrum AB: Alprolix® approved in Switzerland for the treatment of haemophilia B

Alprolix® approved in Switzerland for the treatment of haemophilia B

Swedish Orphan Biovitrum AB (publ) (http://www.sobi.com) (Sobi™) (STO:
SOBI) today announces that the Swiss Agency for Therapeutic Products,
Swissmedic, has approved Alprolix® (eftrenonacog alfa) for the
treatment of haemophilia B. Alprolix is the only recombinant factor
IX Fc Fusion protein therapy approved in Switzerland for the
treatment of haemophilia B.

"The Swiss approval of Alprolix is an important milestone for the
haemophilia community, offering the opportunity for people with
haemophilia B to experience prolonged protection from bleeds," said
Krassimir Mitchev, M.D., Ph.D., vice president and medical
therapeutic area head of Haemophilia at Sobi. "We will now focus on
ensuring timely and sustainable access to Alprolix in Switzerland."

Alprolix is indicated for both on-demand and prophylaxis treatment of
previously treated haemophilia B patients. For initiation of
prophylaxis one dose every seven days or every 10 days can be
administered,

with the ability to adjust the dosing interval based on individual
response.

- - -

About Haemophilia B
Haemophilia is a rare, genetic disorder in which the ability of a
person's blood to clot is impaired. Haemophilia B occurs in about one
in 25,000 male births annually, and more rarely in females. The World
Federation of Haemophilia estimates that approximately 28,000 people
are currently diagnosed with haemophilia B worldwide[i]
(http://#_edn1)

People with haemophilia B experience bleeding episodes that can cause
pain, irreversible joint damage and life-threatening haemorrhages.
Prophylactic infusions of factor IX can temporarily replace the
clotting factor needed to control bleeding and prevent new bleeding
episodes.[ii] (http://#_edn2) The World Federation of Hemophilia
recommends prophylaxis as the optimal therapy as it can prevent
bleedings and joint destruction.[iii] (http://#_edn3)

About Alprolix®
Alprolix® (eftrenonacog alfa) is a recombinant clotting factor therapy
developed for haemophilia B by fusing factor IX to the Fc portion of
immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the
body). This enables Alprolix to use a naturally occurring pathway to
prolong the time the therapy remains in the body. While Fc fusion
technology has been used for more than 15 years, Sobi and Biogen are
the first companies to utilise it in the treatment of haemophilia.

Alprolix is currently approved for the treatment of haemophilia B in
the EU, Iceland, Liechtenstein and Norway, as well as the United
States, Canada, Japan, Australia, New Zealand and other countries. As
with any factor replacement therapy, allergic-type hypersensitivity
reactions and development of inhibitors may occur following
administration of Alprolix.

About the Sobi and Biogen collaboration
Sobi and Biogen collaborate on the development and commercialisation
of Elocta/Eloctate and Alprolix. Sobi has final development and
commercialisation rights of Elocta and Alprolix in the Sobi territory
(essentially Europe, North Africa, Russia and most Middle Eastern
markets). Biogen has manufacturing responsibility for Eloctate and
Alprolix and has final development and commercialisation rights in
North America and all other regions in the world excluding the Sobi
territory.

About Sobi™
Sobi is an international specialty healthcare company dedicated to
rare diseases. Sobi's mission is to develop and deliver innovative
therapies and services to improve the lives of patients. The product
portfolio is primarily focused on Haemophilia, Inflammation and
Genetic diseases. Sobi also markets a portfolio of specialty and rare
disease products across Europe, the Middle East, North Africa and
Russia for partner companies. Sobi is a pioneer in biotechnology with
world-class capabilities in protein biochemistry and biologics
manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and about 700 employees. The share (STO: SOBI) is listed
on Nasdaq Stockholm. More information is available at www.sobi.com.

For more information please contact

+--------------------------+------------------------------+
|Media relations |Investor relations |
+--------------------------+------------------------------+
|Linda Holmström, Senior |Jörgen Winroth, Vice |
|Communications Manager |President, Head of Investor |
| |Relations |
+--------------------------+------------------------------+
|T: + 46 708 73 40 95, + 46|T: +1 347-224-0819, +1 212-579|
|8 697 31 74 |-0506, +46 8 697 2135 |
+--------------------------+------------------------------+
|linda.holmstrom@sobi.com |jorgen.winroth@sobi.com |
+--------------------------+------------------------------+

----------------------------------------------------------------------

[i] (http://#_ednref1) World Federation of Hemophilia. About Bleeding
Disorders - Frequently Asked Questions. Available at:
http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B
(http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.wfh....).
Accessed on: February 11, 2016.

[ii] (http://#_ednref2) World Federation of Hemophilia. About Bleeding
Disorders - Frequently Asked Questions. Available at:
http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B. Accessed on:
June 17, 2016.

[iii] (http://#_ednref3) Guideline for the management of hemophilia,
World Federation of Hemophilia, 2nd edition,
http://www1.wfh.org/publication/files/pdf-1472.pdf. Accessed on
December 2015

Swedish Orphan Biovitrum AB
Postal address SE-112 76 Stockholm, Sweden
Phone: +46 8 697 20 00 www.sobi.com

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http://news.cision.com/swedish-orphan-biovitrum-ab/r/alprolix--approved-...
http://mb.cision.com/Main/14266/2109250/580542.pdf

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